Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that SGX945 (dusquetide) has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of Behçet's Disease. 

The PIM designation is the first step and a prerequisite towards inclusion in the UK Early Access to Medicines Scheme (EAMS). EAMS offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines much earlier than they would normally be accessible. The criteria products must meet to obtain the PIM designation are:

1. Criterion 1 – The condition is life-threatening or seriously debilitating with a high unmet medical need.
2. Criterion 2 – The medicinal product is likely to offer a major advantage over methods of preventing, diagnosing or treating the condition currently used in the UK.
3. Criterion 3 – The potential adverse effects of the medicinal product are likely to be outweighed by the potential benefits, allowing for a reasonable expectation of a positive benefit risk balance. 

"We are excited that the MHRA agrees that dusquetide meets the specified criteria for PIM designation based on the Phase 2 clinical data in Behçet's Disease, in conjunction with the consistency that has been observed in previous clinical studies in oral mucositis," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We look forward to working with the MHRA to advance the program and leverage the potential benefits of the EAMS scheme to make this important product available to patients and physicians facing the challenges of Behçet's Disease."